DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 80
- Primary Endpoint
- High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
Study Overview
Brief Summary
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must sign an Informed Consent document;
- •Wear toric soft contact lenses within the protocol-specified range;
- •Cylinder equal or higher than -0.75 diopters (D) in both eyes;
- •Have an acceptable fit with both study contact lenses;
- •Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
- •Best corrected visual acuity (BCVA) of 20/30 Snellen;
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Require presbyopic correction;
- •Any ocular condition observed during examination at the enrollment visit;
- •History of herpetic keratitis, ocular surgery or irregular cornea;
- •Pregnant or lactating;
- •Participation in any clinical trial within 30 days of the enrollment visit;
- •Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Intervention: Nelfilcon A toric contact lenses (Device)
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Intervention: Etafilcon A toric contact lenses (Device)
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Intervention: Nelfilcon A toric contact lenses (Device)
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
Intervention: Etafilcon A toric contact lenses (Device)
Outcomes
Primary Outcomes
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
Time Frame: Day 10, each product
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Secondary Outcomes
- Lens Oscillation at Blink at Day 10(Day 10, each product)